2019
A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors.
Chong C, Bauer T, Laurie S, Patel M, Yamamoto N, Davenport T, Geng J, Gibson N, Vallaster M, LoRusso P. A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2019, 37: tps3166-tps3166. DOI: 10.1200/jco.2019.37.15_suppl.tps3166.Peer-Reviewed Original ResearchDose-limiting toxicityMetastatic solid tumorsFirst treatment cycleSolid tumorsEvaluable patientsPrimary endpointTreatment cyclesPhase 1bPreliminary anti-tumor activityMDM2-p53 antagonistsNon-squamous NSCLCDose-escalation studyDose-escalation trialSoft tissue sarcomasNumber of patientsTP53 wild-type statusWild-type statusAnti-tumor activityMDM2 amplification statusTumor protein 53New anti-cancer drugsIA/IBOpen labelRECIST v1.1Brain metastases
2013
Pharmacokinetics and safety of an oral ALK inhibitor, ASP3026, observed in a phase I dose escalation trial.
Patnaik A, LoRusso P, Ball H, Bahceci E, Yuen G, Papadopoulos K, Kittaneh M, Tolcher A. Pharmacokinetics and safety of an oral ALK inhibitor, ASP3026, observed in a phase I dose escalation trial. Journal Of Clinical Oncology 2013, 31: 2602-2602. DOI: 10.1200/jco.2013.31.15_suppl.2602.Peer-Reviewed Original ResearchAdvanced malignanciesDay 28Phase 1 dose-escalation trialALT/AST increasesCohort expansion phaseDose-escalating cohortsDose-escalation partECOG PS 2Grade 2 nauseaOral ALK inhibitorPre-dose valuesDose-escalation trialGrade 3 rashALK fusion geneALK receptor tyrosine kinaseAbdominal painCommon AEsEscalation trialMedian tmaxDaily dosingOral inhibitorNon-linear PKClinical activityALK inhibitorsPromising safetyPhase I study of REGN421 (R)/SAR153192, a fully-human delta-like ligand 4 (Dll4) monoclonal antibody (mAb), in patients with advanced solid tumors.
Jimeno A, LoRusso P, Strother R, Diamond J, Plato L, Younger A, Messersmith W, Kittaneh M, Sawyer D, Adriaens L, Liu L, Kao R, DiCioccio A, Brownstein C, Lowy I, Trail P, Chiorean E. Phase I study of REGN421 (R)/SAR153192, a fully-human delta-like ligand 4 (Dll4) monoclonal antibody (mAb), in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2502-2502. DOI: 10.1200/jco.2013.31.15_suppl.2502.Peer-Reviewed Original ResearchAbdominal painVentricular dysfunctionSolid tumorsGrade 3 nauseaGrade 3/4 AEsPhase II doseRight ventricular dysfunctionAcceptable safety profileAdvanced solid tumorsDose-escalation trialAnti-tumor activityBNP increaseCA125 responseHuman Dll4Prolonged SDsEscalation trialExpansion cohortPulmonary hypertensionLaboratory abnormalitiesDose escalationAdvanced cancerSafety profileFrequent treatmentHypertensionNausea
2011
MEDI-573 as a novel approach to IGF-1R and IR-A signaling inhibition by blocking IGF ligands: Phase I PK/PD, safety data, and disease linkage studies in breast cancer.
Haluska P, Huang J, Lam B, Liang M, Huang W, LoRusso P, Menefee M, LaVallee T, Yao Y, Viner J. MEDI-573 as a novel approach to IGF-1R and IR-A signaling inhibition by blocking IGF ligands: Phase I PK/PD, safety data, and disease linkage studies in breast cancer. Journal Of Clinical Oncology 2011, 29: 271-271. DOI: 10.1200/jco.2011.29.27_suppl.271.Peer-Reviewed Original ResearchMEDI-573Breast cancerIR-B ratioIGF-1RGlucose levelsPhase Ib/II studyDrug-related SAEsAdvanced solid tumorsDose-escalation trialBreast cancer subsetsFree IGF-1Plasma glucose levelsFavorable PK profileDetermination of MTDPK/PDAdjacent normal tissuesStable diseaseII studyIV infusionAntidrug antibodiesSafety profileInsulin resistanceSignificant changesAcceptable safetyTumor response
2009
Tremelimumab in combination with exemestane as novel immunotherapy for patients with advanced breast cancer
Vonderheide R, LoRusso P, Khalil M, Heath E, Khaira D, Soulieres D, Dorazio P, Mariani G, Usari T, Domchek S. Tremelimumab in combination with exemestane as novel immunotherapy for patients with advanced breast cancer. Journal Of Clinical Oncology 2009, 27: 3034-3034. DOI: 10.1200/jco.2009.27.15_suppl.3034.Peer-Reviewed Original ResearchBreast cancerHormone receptor breast cancerAnti-CTLA4 monoclonal antibodySingle-agent doseUnknown receptor statusCycles of therapyPhase II doseSingle-agent antitumor activityAdvanced breast cancerDose-escalation trialSerum transaminase elevationTumor response evaluationCycle 1Assessment of safetyStable diseaseAdvanced diseasePrimary endpointSecondary endpointsTransaminase elevationAutoimmune thyroiditisHormone replacementNovel immunotherapiesObjective responsePharmacokinetic interactionsReceptor status
2004
Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer
Rinehart J, Rothermel J, Anderson J, Lorusso P. Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer. Journal Of Clinical Oncology 2004, 22: 3100-3100. DOI: 10.1200/jco.2004.22.14_suppl.3100.Peer-Reviewed Original ResearchPhase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer
Rinehart J, Rothermel J, Anderson J, Lorusso P. Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer. Journal Of Clinical Oncology 2004, 22: 3100-3100. DOI: 10.1200/jco.2004.22.90140.3100.Peer-Reviewed Original Research
2003
546 A phase I dose-escalation trial of ZD6126 administered as 5 daily dose every 3 weeks to patients with cancer refractory to other treatments
Budd G, Evelhoch J, Langmuir P, Veiero J, Shepherdson K, LoRusso P. 546 A phase I dose-escalation trial of ZD6126 administered as 5 daily dose every 3 weeks to patients with cancer refractory to other treatments. European Journal Of Cancer Supplements 2003, 1: s165. DOI: 10.1016/s1359-6349(03)90578-7.Peer-Reviewed Original Research